Description

Posaconazole Impurity 45 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antifungal drug Posaconazole by serving as a key marker in impurity profiling and method development. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and contract research organizations (CROs) engaged in the development and manufacturing of Posaconazole and its formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Posaconazole Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity analysis.
• Quality Control & Assurance: Employed in routine batch testing within QC laboratories to monitor and control impurity levels, ensuring product consistency and compliance with ICH guidelines.
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of Posaconazole.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Facilitates studies on the degradation pathways, metabolism, and synthesis of Posaconazole and related triazole antifungals.

Basic Information

Item	Detail
Product Name	Posaconazole Impurity 45
CAS No.	1388148-30-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 45; Posaconazole Impurity F; Posaconazole EP Impurity F; Posaconazole USP Impurity; (2R,3S)-2-(2,4-Difluorophenyl)-3-(5-{4-[(3R,5R)-5-{(2S,3S)-2-hydroxy-3-[4-(1H-1,2,4-triazol-1-yl)phenyl]butanamido}-1-(1H-1,2,4-triazol-1-yl)pentan-3-yl]phenoxy}pentyl)-1,2,4-triazol-1-ium-1-ide (IUPAC-based); UNII-XXXX; SCH 56592 Impurity 45
EINECS	Contact for details

Quality Control

Every batch of Posaconazole Impurity 45 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using techniques such as HPLC, NMR, and MS to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.